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ISO 9001 : 2008

QUALITY MANAGEMENT SYSTEMS


REQUIREMENTS
(THIRD REVISION)

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1. Scope
1.1 General
This International Standard specifies requirements for a quality
management system where an organization.
a)

Needs to demonstrate its ability to consistently provide product


that meets customer and applicable statutory and regulatory
requirements, and

b)

Aims to enhance customer satisfaction through the effective


application of the system, including processes for continual
improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements

Note 1: In this International Standard, the term product only applies to


a)
Product intended for, or required by, a customer,
b)
Any intended output resulting from the product realization
processes.
Note 2: Statutory and regulatory requirements can be expressed as
legal requirements
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1.2 Application

All requirements of this International Standard are generic and are


intended to be applicable to all organizations, regardless of type, size
and product provided.
Where any requirements of this International Standard cannot be
applied due to the nature of an organization and its product, this can
be considered for exclusion.
Where exclusions are made, claims of conformity to this International
Standard are not acceptable unless these exclusions are limited to
requirements with Clause 7, and such exclusions do not affect the
organizations ability, or responsibility, to provide product that meets
customer and applicable statutory and regulatory requirements.

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2. Normative reference

The following referenced documents are indispensable for the


application of this document. For dated references, only the edition
cited applies. For undated references, the latest edition of the
referenced document (including any amendments) applies.
ISO 9000:2005, Quality management Systems Fundamentals and
vocabulary

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3. Terms and definitions

For the purpose of this document, the terms and definitions given
in ISO 9000 apply.
Throughout the text of this International Standard, wherever the
term product occurs, it can also mean service

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4. Quality management system


4.1 General requirements
The organization shall establish, document, implement and maintain
a quality management system and continually improve its
effectiveness in accordance with the requirements of this
International standards.
The organization shall
a)

Determine the process needed for the quality management system


and their application throughout the organization (see 1.2),

b) Determine the sequence and interaction of these processes,


c)

Determine criteria and methods needed to ensure that both the


operation and control of these processes are effective,
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Continuation of General requirements


d)

Ensure the availability of resources and information necessary to


support the operation and monitoring of these processes,

e)

Monitor, measure where applicable, and analyse these processes, and

f)

Implement actions necessary to achieve planned results and continual


improvement of these processes.

These processes shall be managed by the organization in accordance with


the requirements of this International Standard.
Where an organization chooses to outsource any process that affects
product conformity to requirements, the organization shall ensure
control over such processes. The type and extent of control to be
applied to these outsourced processes shall be defined within the
quality management system.

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Continuation of General requirements


Note 1: Processes needed for the quality management system referred to
above
include process for management activities, provision of
resources, product realization, measurement, analysis and
improvement.
Note 2: An outsourced process is a process that the organization needs for
its quality management system and which the organization chooses to
have
performed by an external party.
Note 3: Ensuring control over outsourced processes does not absolve the
organization of the responsibility of conformity to all customer, statutory
and regulatory requirements. The type and extent of control to be
applied to the outsourced process can be influenced by factors such as
a)
b)
c)

The potential impact of the outsourced process on the organizations


capability to provide product that conforms to requirements,
The degree to which the control for the process is shared,
The capability of achieving the necessary control through the application
of 7.4.

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4.2 Documentation requirements


4.2.1 General
The quality management system documentation shall include the
following,
a)

Documented statements of a quality policy and quality objectives,

b)

A quality manual,

c)

Documented procedure and records required by this international


standard, and

d)

Documents, including records, determined by the organization to


be necessary to ensure the effective planning, operation and
control of its processes.
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Continuation of the documentation


requirements
Note 1: Where the term documented procedure appears within this
International
Standard, this means that the procedure is
established, documented, implemented and maintained. A single
document may address the
requirements for one or more
procedures. A requirement for a
documented procedures may be
covered by more than one document.
Note 2: The extent of the quality management system documentation
can differ from one organization to another due to
a)
b)
c)

The size of organization and type of activities,


The complexity of processes and their interactions, and
The competence of personnel.

Note 3: The documentation can be in any form or type of medium

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4.2.2 Quality manual

The organization shall establish and maintain a quality manual that


includes,
a)

The scope of the quality management system, including details of


and justification for any exclusions (see 1.2)

b)

The documented procedures established for the quality


management system, or reference to them, and

c)

A description of the interaction between the processes of the


quality management system.

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4.2.3 Control of documents:

Documents required by the quality management system shall be controlled. Records are a special
type of document and shall be controlled according to the requirements given in 4.2.4
A documented procedure shall be established to define the controls needed,
a)

To approve documents for adequacy prior to issue,

b)

To review and update as necessary and re-approve documents,

c)

To ensure that changes and the current revision status of documents are identified,

d)

To ensure that relevant versions of applicable documents are available at points of use,

e)

To ensure that documents remain legible and readily identifiable,

f)

To ensure that documents of external origin determined by the organization to be necessary


for the planning and operation of the quality management system are identified and their
quality management system are identified and their distribution controlled, and

g)

To prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose.

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4.2.4 Controls of Records:

Records established to provide evidence of conformity to requirements


and of the effective operation of the quality management system
shall be controlled.
The organization shall establish a documented procedure to define the
controls needed for the identification, storage, protection, retrieval,
retention and disposition of records.
Records shall remain legible, readily identifiable and retrievable.

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5. Management Responsibility
5.1 Management commitment:
Top management shall provide evidence of its commitment to the
development and implementation of the quality management
system and continually improving its effectiveness by
a)

Communicating to the organization the importance of meeting


customer as well as statutory and regulatory requirements,

b)

Establishing the quality policy,

c)

Ensuring that quality objectives are established,

d)

Conducting management reviews, and

e)

Ensuring the availability of resources.

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5.2 Customer Focus

Top management shall ensure that customer requirements are


determined and are met with the aim of enhancing customer
satisfaction (see 7.2.1 and 8.2.1).

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5.3 Quality Policy

Top management shall ensure that the quality policy.


a)

It is appropriate to the purpose of the organization,

b)

It includes a commitment to comply with requirements and


continually improve the effectiveness of the quality management
system

c)

Provides a frame work for establishing and reviewing quality


objectives,

d)

It is communicated and understood within the organization, and

e)

It is reviewed for continuing suitability.

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5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those
needed to meet requirements for product [see 7.1], are established at
relevant functions and levels within the organization. The quality
objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality management system planning


Top management shall ensure that
a) The planning of the quality management system is carried out in order to
meet the requirements given in 4.1, as well as the quality objectives, and
b) The integrity of quality management system is maintained when changes
to the quality management system are planned and implemented.

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5.5 Responsibility, authority and communication


5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities
are defined and communicated within the organization.

5.5.2 Management representative

Top management shall appoint a member of the organizations


management who irrespective of other responsibilities, shall have
responsibility and authority that includes,

a) Ensuring that processes needed for the quality management system


are established, implemented and maintained,
b) Reporting to top management on the performance of the quality
management system and any need for improvement, and
c) Ensuring the promotion of awareness of customer requirements
throughout the organization.
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Note: The responsibility of a management representative can


include liaison with external parties on matters relating to the
quality management system.
5.5.3 Internal Communication
Top management shall ensure that appropriate communication
processes are established within the organization and that
communication takes place regarding the effectiveness of the
quality management system.

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5.6 Management Review


5.6.1 General
Top management shall review the organizations quality
management system, at planned intervals, to ensure its
continuing suitability, adequacy and effectiveness. This review
shall include assessing opportunities for improvement and the
need for changes to the quality management system,
including the quality policy and quality objectives.
Records from management reviews shall be maintained.

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5.6.2 Review Input


The input to management review shall include information on
a)
b)
c)
d)
e)
f)
g)

Results of audits
Customer feedback,
Process performance and product conformity,
Status of preventive and corrective actions,
Follow up actions from previous management reviews,
Changes that could affect the quality management system,
and
Recommendation for improvement.
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5.6.3 Review output


The output from the management review shall include any
decisions and actions related to
a)
b)
c)

Improvement of the effectiveness of the quality


management system and its processes,
Improvement of product related to customer requirements,
and
Resource needs

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6. Resource Management
6.1 Provision of resources

The organization shall determine and provide the resources needed


a)

To implement and maintain the quality management system and


continually improve its effectiveness, and

b)

To enhance customer satisfaction by meeting customer


requirements.

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6.2. Human Resources


6.2.1 General
Personnel performing work affecting conformity to product
requirements shall be competent on the basis of appropriate
education, training, skills and experience.
Note: Conformity to product requirements can be affected
directly or indirectly by personnel performing any task within
the quality management system.

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6.2.2 Competence, training and awareness


The organization shall
a)

Determine the necessary competence for personnel performing work affecting


conformity to product requirements,

b)

Where applicable, provide training or take other actions to achieve the


necessary competence,

c)

Evaluate the effectiveness of the actions taken,

d)

Ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives,
and

e)

Maintain the appropriate records of education, training, skills and experience


(see 4.2.4)
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6.3 Infrastructure
The organization shall determine, provide and maintain the
infrastructure needed to achieve conformity to product
requirements, infrastructure includes, as applicable,
a)

Buildings, workspace, and associated utilities,

b)

Process equipment (both hardware and software), and

c)

Supporting services (such as transport, communication or


information systems).

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6.4 Work Environment


The organization shall determine and manage the work environment
needed to achieve conformity to product requirements.
Note: The term work environment relates to those conditions under
which work is performed including physical, environmental and other
factors (such as noise, temperature, humidity, lighting or weather).

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7. Product Realization
7.1 Planning of product realization
The organization shall plan and develop the processes needed for product
realization. Planning of product realization shall be consistent with the
requirements of the other processes of the quality management
system (see 4.1)
In Planning product realization, the organization shall determine the
following, as appropriate:
a)

Quality objectives and requirements for the product;

b)

The need to establish processes and documents, and to provide


resources specific to the product;

c)

Required verification, validation, monitoring, measurement, inspection


and test activities specific to the product and the criteria for product
acceptance;

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Continuation of 7.1 Planning of product


realization
d)

Records needed to provide evidence that the realization


processes and resulting product meet requirements (see 4.2.4)

The output of this planning shall be in a form suitable for the


organizations method of operations.
NOTE 1: A document specifying the processes of the quality
management system (including the product realization
processes) and the resources to be applied to a specific
product, project or contract can be referred to as a quality plan.
NOTE 2: The organization may also apply the requirements given in
7.3 to the development of product realization processes.
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7.2 Customer related process


7.2.1 Determination of requirements related to
the product
The organization shall determine
a)

Requirements specified by the customer, including the


requirements for delivery and post-delivery activities,

b)

Requirements not stated by the customer but necessary for


specified or intended use, where known,

c)

Statutory and regulatory requirements applicable to the product,


and

d)

Any additional requirements considered necessary by the


organization.

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NOTE: Post delivery activities include, for example, actions


under
warranty provisions, contractual obligation such as
maintenance services, and supplementary services such
as recycling or final disposal.

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7.2.2 Review of requirements related to the


product
The organization shall review the requirements related to the
product. This review shall be conducted prior to the
organizations commitment to supply a product to the
customer (e.g submission of tenders, acceptance of
contracts or orders, acceptance of changes to contracts or
orders) and shall ensure that
a)

Product requirements are defined,

b)

Contract or order requirements differing from those


previously expressed are revolved, and

c)

The organization has the ability to meet the defined


requirements.

Records of the results of the review and actions arising from the
review shall be maintained (see 4.2.4).
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Continuation of 7.2.2
Where the customer provides no documented statement of
requirement, the customer requirements shall be confirmed
by the organization before acceptance.
Where product requirements are changed, the organization shall
ensure that relevant documents are amended and that
relevant personnel are made aware of the changed
requirements.
NOTE: In some situations, such as internet sales, a formal review
is impractical for each order. Instead the review can cover
relevant product information such as catalogues or
advertising material.
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7.2.3 Customer communication


The organization shall determine and implement effective
arrangements for communicating with customers in relation
to
a)

Product information,

b)

Enquiries, contracts or order handling, including


amendments, and

c)

Customer feedback, including customer complaints

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